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Proteomic Biomarker Tests in Blood Samples from Children with Autism Spectrum Disorder (ASD)

Recruitingn/aAges 10 Months - 19 YearsAllBenjamin Gesundheit
NCT02168868 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Behavioral testing is the gold standard for diagnosing autism spectrum disorder (ASD). These tests, including ADOS and ADI-R, are subjective, require trained staff to administer, are time-consuming, and can only be administered at a later age. Blood-, urine- or stool-based diagnostic biomarker test for ASD would enable objective early diagnosis, potentially even before clinical symptoms are present, eliminate the need for trained staff and enable early intervention. Such a test would not only conserve money and time but would also provide clues to ASD pathogenesis. To date, no definitive treatment exists for ASD. Most therapies are symptom-focused, generally focusing on behavioral, social and communication skills. Recent works have reported on promising outcomes of mesenchymal stem cell (MSC) treatment of children with ASD. MSCs are multipotent, non-hematopoietic, easily isolatable and

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Male and female children 2. Child aged 2-12 years with diagnosed ASD according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV (299.00) or DSM-V (299.00) OR Child aged 2-18 years diagnosed ASD according to DSM-IV (299.00) or DSM-V (299.00) AND scheduled to undergo stem cell transplantation OR Child aged 10-19 months not diagnosed with ASD but with a sibling diagnosed with ASD according to (DSM)-IV (299.00) or DSM-V (299.00) (herein termed "high-risk infants") OR Mothers of recruited high-risk infants OR A typically developing child aged 2-12 years with no signs of ASD or history of ASD in the immediate family 3. Informed consent signed by the parent/legal guardian Exclusion Criteria: 1. Child and/or mother completed treatment with systemic steroids or immune suppressants less than 4 weeks before the screening visit 2. Child and/or mother diagnosed with severe infectious diseases or sepsis over the last 6 months 3. Child with ASD treated for a severe convulsive disorder (intractable seizures) 4. Child and/or mother with hematological or malignant disorder 5. For children in the SCT cohort: No new planned immune-modulating treatment (other than SCT) for at least 6 months before or after planned stem cell transplantation date 6. If the PI suspects that the participant will not comply with study requirements, the participant may be excluded.
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What it tests

  • Blood draw
  • Stool Sample Collection
  • Urine Sample Collection
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Where

1 site
Shaare Zedek Medical Center
Jerusalem, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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